A Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

Study Evaluating Safety and Efficacy of BCMA-Targeted Prime CAR-T Cell in Patients with Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma; Multiple Myeloma in Relapse; Neoplasm, Plasma Cell
• Intervention / Treatment: Biological: BCMA targeted prime CAR-T cells

Detailed Description

There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of prime CAR- T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Zhi Yang, PhD; Phone Number: 86-13206140093; Email: yangzhi@precision-biotech.com

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • 920th Hospital of Joint Logistics Support Force
      • Contact: Sanbin Wang, MD
      • Contact: Sanbin Wang, MD; Email: Sanbin1011@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed written informed consent;

2. Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:

   1. Failed to standard chemotherapy regimens;
   2. Relapse after complete remission, high-risk and / or refractory patients ;
   3. Relapse after hematopoietic stem cell transplantation;
3. Evidence for cell membrane BCMA expression
4. All genders, ages: 18 to 75 years#
5. The expect time of survive is above 3 months;
6. KPS>60
7. No serious mental disorders ;
8. Left ventricular ejection fraction ≥50%
9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
10. Sufficient renal function defined by creatinine clearance≤2 x ULN;
11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. With single or venous blood collection standards, and no other cell collection contraindications;

13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

1. Previous history of other malignancy;
2. Presence of uncontrolled active infection;
3. Evidence of disorder that need the treatment by glucocorticoids;
4. Active or chronic GVHD
5. The patients treatment by inhibitor of T cell
6. Pregnant or breasting-feeding women;
7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BCMA targeted prime CAR-T cells treat; Patients will be be treated with BCMA targeted prime CAR-T cells	Biological: BCMA targeted prime CAR-T cells; BCMA targeted prime CAR-T cell therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events that related to treatment	Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)	2 years
The response rate of BCMA targeted prime CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA targeted prime CAR-T cells therapy	The response rate of BCMA targeted prime CAR-T treatment will be recorded and assessed according to the IMWG	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of clonal plasma cells in bone marrow	In vivo (bone marrow) quantity of clonal plasma cells	1 years
Rate of BCMA targeted prime CAR-T cells in bone marrow and peripheral blood	In vivo (bone marrow and peripheral blood) rate of BCMA targeted prime CAR-T cells were determined by means of flow cytometry	2 years
Quantity of BCMA targeted prime CAR copies in bone marrow and peripheral blood	In vivo (bone marrow and peripheral blood) quantity of BCMA targeted prime CAR copies were determined by means of qPCR	2 years
Levels of IL-6 in Serum	In vivo (Serum) quantity of IL-6	1years
Duration of Response (DOR) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma	DOR will be assessed from the first assessment of sCR/CR/VGPR/PR to the first assessment of recurrence or progression of the disease or death from any cause (censored)	2 years
Progress-free survival(PFS) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma	PFS will be assessed from the first prime CAR-T cell infusion to death from any cause or the first assessment of progression (censored)	2 years
Overall survival(OS) of BCMA targeted prime CAR-T treatment in patients with refractory/relapsed multiple myeloma	OS will be assessed from the first prime CAR-T cell infusion to death from any cause (censored)	2 years

Collaborators and Investigators

• Sponsor: Chongqing Precision Biotech Co., Ltd
• Investigators: Principal Investigator: Sanbin Wang, MD, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China; Principal Investigator: Cheng Qian, PhD, Chongqing University Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Multiple Myeloma; BCMA; prime Chimeric Antigen Receptor T Cell
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: PBC027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No